Generic Name: azathioprine (ay za THYE oh preen)
Brand Names: Azasan, Imuran
What is azathioprine?
Azathioprine lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.
Azathioprine is used to prevent your body from rejecting a transplanted kidney. It is also used to treat symptoms of rheumatoid arthritis.
Azathioprine may also be used for purposes not listed in this medication guide.
What is the most important information I should know about azathioprine?
Do not use azathioprine if you are pregnant. It could harm the unborn baby. Some people using azathioprine have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using azathioprine or similar medicines to treat Crohn's disease or ulcerative colitis. Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Azathioprine can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.
If you need to have surgery, tell the surgeon ahead of time that you are using azathioprine. You may need to stop using the medicine for a short time.
This medication can affect fertility (your ability to have children), whether you are a man or a woman. Talk with your doctor if you have concerns about this.
Do not receive a "live" vaccine while you are being treated with azathioprine and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.
What should I discuss with my healthcare provider before taking azathioprine?
You should not take this medication if you are allergic to azathioprine. Some people using azathioprine have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using azathioprine or similar medicines to treat Crohn's disease or ulcerative colitis.
However, people with autoimmune disorders (including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.
To make sure you can safely take azathioprine, tell your doctor if you have any of these other conditions:
liver disease;
any type of viral, bacterial, or fungal infection; or
if you have recently received chemotherapy treatments with medications such as cyclophosphamide (Cytoxan), chlorambucil (Leukeran), melphalan (Alkeran).
FDA pregnancy category D. Do not use azathioprine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Azathioprine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using azathioprine.
This medication can affect fertility (your ability to have children), whether you are a man or a woman. Talk with your doctor if you have concerns about this.
How should I take azathioprine?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Take azathioprine with a full glass of water. Take azathioprine with food to lessen stomach upset. Azathioprine can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly. If you need surgery, tell the surgeon ahead of time that you are using azathioprine. You may need to stop using the medicine for a short time. Store at room temperature away from moisture, heat, and light.
See also: Azathioprine dosage (in more detail)
What happens if I miss a dose?
If you take this medicine once daily and you miss a dose, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
If you take this medicine more than once daily and you miss a dose, take the medicine as soon as you remember. If it is almost time for the next dose, take both doses together, then go back to your regular dosing schedule.
Call your doctor if you have missed more than one dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, bleeding, fever, chills, and other signs of infection.
What should I avoid while taking azathioprine?
Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while using azathioprine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.
Azathioprine side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using azathioprine and call your doctor right away if you have any of these symptoms of lymphoma:
fever, night sweats, weight loss, tiredness;
feeling full after eating only a small amount;
pain in your upper stomach that may spread to your shoulder;
easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Stop using azathioprine and call your doctor at once if you have any of these other serious side effects:
signs of infection (fever, chills, sore throat, body aches, weakness, muscle pain, flu symptoms);
severe nausea, vomiting, or diarrhea;
pain or burning with urination; or
white patches or sores inside your mouth or on your lips.
Less serious side effects may include:
mild upset stomach, nausea, diarrhea, loss of appetite;
hair loss; or
skin rash.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Azathioprine Dosing Information
Usual Adult Dose for Renal Transplant:
Initial dose: 3 to 5 mg/kg orally or IV once a day, beginning at the time of transplant; in a few cases, therapy has been started 1 to 3 days before transplantation
Maintenance dose: 1 to 3 mg/kg orally or IV once a day
Usual Adult Dose for Rheumatoid Arthritis:
Initial dose: 1 mg/kg (50 to 100 mg) orally or IV per day given in 1 to 2 divided doses
Titration: May increase in increments of 0.5 mg/kg/day (up to a maximum dose of 2.5 mg/kg/day), beginning at 6 to 8 weeks and thereafter at 4 week intervals
Maintenance dose: Gradual dosage reduction should be attempted to reduce risk of toxicity. Maintenance therapy should be at the lowest effective dose. The dose can be lowered by 0.5 mg/kg or approximately 25 mg/day every 4 weeks.
Therapeutic response occurs after several weeks of therapy, usually 6 to 8 weeks, and should be tried for at least 12 weeks. Patients not improved after 12 weeks can be considered refractory. Azathioprine may be continued long-term in patients with clinical response.
Usual Adult Dose for Crohn's Disease -- Acute:
Studies:
1.5 to 4 mg/kg per day for 10 days up to 52 weeks
Usual Adult Dose for Crohn's Disease -- Maintenance:
Studies:
1.5 to 4 mg/kg per day for 10 days up to 52 weeks
Usual Adult Dose for Chronic Inflammatory Demyelinating Polyradiculoneuropathy:
Study (n=14)
2 to 3 mg/kg orally once a day for 9 months
Usual Adult Dose for Atopic Dermatitis:
Study (n=37)
2.5 mg/kg orally once a day, in the morning, for 3 months
Usual Adult Dose for Sarcoidosis:
Study (n=11)
Initial dose: 2 mg/kg per day in combination with prednisolone 0.6 to 0.8 mg/kg per day, with prednisolone reduced to 0.1 mg/kg within 2 to 3 months
Maintenance dose: 2 mg/kg per day with prednisolone 0.1 mg/kg per day for 21 to 22 months
Usual Adult Dose for Ulcerative Colitis:
Study (n=9)
IV: 20 to 40 mg/kg via IV infusion over 36 hours or 40 mg/kg as three 8-hour infusions over 3 days followed by oral azathioprine
Oral: 2 mg/kg orally per day beginning the day after completion of the IV loading dose
Study (n=12)
50 mg per day for 2 weeks, then 2 to 2.5 mg/kg per day plus mesalamine 500 mg orally 3 times a day; these drugs were started immediately after signs of remission was achieved (mean: 14.5 days) with cyclosporine IV (4 mg/kg/day)
Usual Adult Dose for Uveitis:
Study (n=14)
Treatment of choroidal neovascularization: 1 to 1.5 mg/kg orally per day, in combination with prednisolone and cyclosporine
Usual Adult Dose for Multiple Sclerosis:
Study (n=6)
Patients refractory to interferon beta-1b:
Initial dose: Azathioprine should be titrated up to 1.5 mg/kg per day over 1 month, followed by 50 mg increments in 6-month intervals, concomitantly with 8 million international units subcutaneous interferon beta-1b on alternate days
Maintenance dose: 2 mg/kg per day
Usual Adult Dose for Systemic Lupus Erythematosus:
Studies:
1 to 3 mg/kg actual body weight (ABW)/day orally or IV once a day
Study (n=55)
Diffuse proliferative lupus glomerulonephritis: Sequential therapy starting with prednisone (1 mg/kg/day) for 8 to 10 weeks, gradually tapering to maintenance dosage of 5 to 10 mg/day, together with oral cyclophosphamide (1 to 2 mg/kg/day) for 6 to 9 months followed by azathioprine 50 to 100 mg/day
Usual Adult Dose for Chronic Active Hepatitis:
Study (n=72)
Autoimmune hepatitis: 1 to 2 mg/kg per day, concomitantly with prednisolone (5 to 15 mg/day) for a minimum of 1 year (average 5 years)
Usual Adult Dose for Takayasu's Arteritis:
Study (n=15)
2 mg/kg ABW/day for 1 year in combination with prednisolone taper
Usual Pediatric Dose for Atopic Dermatitis:
Study (n=37)
Greater than 17 years: 2.5 mg/kg orally once daily, in the morning, for 3 months
Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis:
Initial dose: 3 to 5 mg/kg orally or IV once a day, beginning at the time of transplant
Maintenance dose: 1 to 3 mg/kg orally or IV once a day
Usual Pediatric Dose for Eczema:
Study (n=91)
Greater than 6 years: 2.5 to 3.5 mg/kg per day in patients with normal levels of thiopurine methyltransferase
Usual Pediatric Dose for Systemic Lupus Erythematosus:
Case Study (n=67)
Lupus Nephritis:
Greater than 5 years: 2 to 3 mg/kg per day (maximum dose: 150 mg/day)
Dose should be titrated to maintain a total white blood cell count between 3 and 4 x 10(3) cells/mL.
What other drugs will affect azathioprine?
Before taking azathioprine, tell your doctor if you are taking, have taken, or need to take any of the following medicines:
allopurinol (Zyloprim);
mercaptopurine (Purinethol);
methotrexate (Rheumatrex, Immunex);
a blood thinner such as warfarin (Coumadin, Jantoven);
cyclosporine (Gengraf, Neoral, Sandimmune);
olsalazine (Dipentum), or sulfasalazine (Azulfidine);
sulfamethoxasole and trimethoprim (Bactrim, Septra, Sulfatrim, SMX-TMP, others); or
an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik).
This list is not complete and other drugs may interact with azathioprine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More azathioprine resources
- Azathioprine Side Effects (in more detail)
- Azathioprine Dosage
- Azathioprine Use in Pregnancy & Breastfeeding
- Drug Images
- Azathioprine Drug Interactions
- Azathioprine Support Group
- 25 Reviews for Azathioprine - Add your own review/rating
- azathioprine Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information
- Azasan Advanced Consumer (Micromedex) - Includes Dosage Information
- Azasan Prescribing Information (FDA)
- Azathioprine Prescribing Information (FDA)
- Azathioprine Monograph (AHFS DI)
- Azathioprine Professional Patient Advice (Wolters Kluwer)
- Azathioprine MedFacts Consumer Leaflet (Wolters Kluwer)
- Imuran Prescribing Information (FDA)
Compare azathioprine with other medications
- Atopic Dermatitis
- Autoimmune Hepatitis
- Behcet's Disease
- Biliary Cirrhosis
- Bullous Pemphigoid
- Chronic Active Hepatitis
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Cogan's Syndrome
- Crohn's Disease
- Crohn's Disease, Acute
- Crohn's Disease, Maintenance
- Dermatomyositis
- Eczema
- Glomerulonephritis
- Idiopathic Thrombocytopenic Purpura
- Inflammatory Bowel Disease
- Multiple Sclerosis
- Myasthenia Gravis
- Myopathy
- Nephrotic Syndrome
- Neurosarcoidosis
- Organ Transplant, Rejection Prophylaxis
- Pemphigoid
- Pemphigus
- Psoriatic Arthritis
- Renal Transplant
- Rheumatoid Arthritis
- Sarcoidosis
- Systemic Lupus Erythematosus
- Takayasu's Arteritis
- Ulcerative Colitis
- Uveitis
Where can I get more information?
- Your pharmacist can provide more information about azathioprine.
See also: azathioprine side effects (in more detail)
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